CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013

CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 is an FDA 510(k)-cleared medical device (K013523) manufactured by Shire Biologics, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 2002. Regulation: 8.